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临床试验/NCT05956184
NCT05956184已完成不适用

Intrauterine Device Insertion and Felt Pain: Which Method is Better?

Ankara City Hospital Bilkent2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2023年7月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
128
试验地点
2
主要终点
Visual Analogue Scale (VAS)

研究概览

简要总结

The aim of this study is to compare the pain score between the direct method and the conventional method in patients who have undergone copper or hormonal intrauterine devices (IUD) for contraception and to find an answer to the question of which method is better.

详细描述

The intrauterine device (IUD) is one of the commonly used methods of contraception due to its effectiveness in providing reliable contraception, its ease of application, non-obstruction of sexual life, affordability, minimal absolute contraindications, and reversibility. Despite this increasing preference, concerns regarding the use of both levonorgestrel-releasing and copper IUDs due to the potential pain and fear of pain during insertion, which has hindered the adoption of this method.

Although the conventional method is used for intrauterine device insertion, the authors defined the direct method, also known as the torpedo technique, in 2006. IUD practitioners have started to prefer this direct method because it is simpler, faster and has fewer insertion steps than the conventional technique. However, IUD practitioners should apply the most painless and tolerable method to women who choose an IUD for contraception. Therefore, in order to understand which method is less painful, patients will be divided into 2 groups as those who have IUD inserted with the conventional method and those who have IUD inserted with the direct method. At the end of the procedure, participants in both groups will be asked to rate the most severe pain they experienced during the procedure according to the Visual Analogue Scale (VAS) (from 0 to 10).

In the conventional method: the anterior lip of the cervix was grasped and pulled with Pozzi forceps, and after entering the uterine cavity with a hysterometry the IUD was inserted.

In the direct method: the anterior lip of the cervix was grasped and pulled with Pozzi forceps, and without using hysterometry the IUD was directly inserted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

盲法说明

The participants will not know which method would be applied to them.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Volunteer to participate in the study
  • Preferring an intrauterine device for the contraceptive method

排除标准

  • Patients with uterine leiomyoma
  • Patients with endometriosis
  • Patients with chronic pelvic pain
  • Patients with familial mediterranean fever
  • Patients who experienced complications during the procedure
  • Patients who developed vasovagal reactions
  • Patients who had previously used an IUD for any reason
  • Patients with uterine anomalies

结局指标

主要结局

Visual Analogue Scale (VAS)

时间窗: Thirty minutes

This is a numeric pain score evaluated as "painless" (score=0) and "worst pain" (score=10). Score \<3 mild pain, 3-6 mild-moderate pain, and \>6 moderate-to-severe pain.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammad İbrahim Halilzade

Doctor

Ankara City Hospital Bilkent

研究点 (2)

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